BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT IV PLUS SAFETY IV CATHETER -RADIOPAQUE

    MDR report key: 3140848 · Received May 24, 2013

    Report

    Report Number
    MW5030340
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SMITH MEDICAL ASO, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013: PT ADMISSION TO OUR ED WITH SEIZURES. DURING THE INITIAL ASSESSMENT AND TREATMENT, RN ATTEMPTED TO PLACE A IV CATHETER INTO THE PT'S RIGHT AC AREA. GOOD BLOOD RETURN BUT NOTED SWELLING IN THE AREA AROUND THE HUB AND REMOVED THE IV CATHETER. THE CATHETER TIP, APPROPRIATELY 1 INCH IN LENGTH WAS MISSING WHEN CATHETER WAS REMOVED FROM THE SITE. RADIOLOGY FILMS WERE TAKEN BUT THE CATHETER WAS RADIOPAQUE. PT WAS TREATED FOR SEIZURES AND ONCE STABILIZED, HE WAS RELEASED WITH INSTRUCTIONS TO RETURN TO ED THE NEXT DAY FOR F/U ON FOREIGN BODY. ON (B)(6) 2013, HE WAS RETURNED AGAIN TO THE ED (VIA EMS) FOR SEIZURE RELATED SYMPTOMS. DURING THIS STAY, A CT/CHEST PULMONARY ANGIOGRAM WAS PERFORMED AND THE FINDINGS INDICATED "SUGGESTING EMBOLIZED FRACTURED PERIPHERAL INTRAVENOUS CATHETER WITHIN A SUBSEGMENTAL PULMONARY ARTERY TO THE LEFT LOWER LOBE. NO EVIDENCE OF PULMONARY INFARCT OR ACUTE INFILTRATES NOTED. PT WAS TREATED FOR SEIZURE ACTIVITY AND RELEASED TO F/U WITH HIS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231113 PROTECT IV PLUS SAFETY IV CATHETER -RADIOPAQUE NONE FOZ SMITH MEDICAL ASO, INC. 3066 JELCO

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR